APPLICATION
ANDA040465
TYPE
ANDA
ORIGINAL APPROVAL
2003-06-30
LATEST ACTION
2018-05-29
ROUTE
INTRAMUSCULAR, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
DICYCLOMINE HYDROCHLORIDE (PRESERVATIVE FREE)Prescription
DICYCLOMINE HYDROCHLORIDE 10MG/ML · INJECTABLE · INJECTION
Approval history
2018-05-29Labeling · Supplement 7 · standardAP
2018-05-29Labeling · Supplement 8 · standardAP
2012-05-10Labeling · Supplement 5AP
2007-10-05Labeling · Supplement 2AP
2003-06-30OriginalAP
Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.